Merck KGaA Says It Plans European Filing on Erbitux

German drugmaker Merck KGaA said Thursday it remains confident it will submit an approval application in Europe for the experimental cancer drug Erbitux in the first half of 2003.

In a statement, Merck said the guidance is based on an ongoing internal analysis of its pivotal clinical trial of Erbitux in 330 patients with advanced colon cancer. A final analysis of the study by an outside independent group of experts will be completed in March 2003.

Merck spokeswoman Phyllis Carter says data from the study will not be made public until the next annual meeting of the American Society of Clinical Oncology, which kicks off on May 31, 2003.

Merck licenses Erbitux from ImClone Systems(IMCL - Cramer's Take - Stockpickr), which is also seeking to get Erbitux approved in the U.S., a process that has been delayed since last December.

ImClone will receive royalty payments from Merck based on European sales of the drug if and when it's approved there. But neither Merck nor ImClone is saying whether data from Merck's European study will help ImClone refile its own Erbitux application with the Food and Drug Administration by early next year.

"We're pleased that Merck remains optimistic about meeting the European regulatory requirements for filing an Erbitux marketing application in the first half of 2003, and we look forward to supporting them in those efforts," said ImClone spokesman Andrew Merrill, declining to speak about ImClone's own plans for the drug.

The 330-patient study conducted by Merck tests Erbitux, by itself, against a combination of Erbitux and the chemotherapy drug irinotecan. In October, TheStreet.com reported that this study failed, based on sources familiar with the study's initial results. These sources, in contact with European doctors involved in the study, said there was no statistically significant difference in response rates between the two arms of the study.